Infinata's BioPharm Insight Releases July Catalyst Monitor Report

June 26, 2013 – Norwood, MA – With a PDUFA decision date of 6 July, Orexo has plans to launch Zubsolv for opioid dependence in September of this year. According to experts interviewed by BioPharm Insight, Zubsolv will face a challenging market launch in the face of upcoming generic competition and reimbursement climate.

Boehringer Ingelheim’s lung cancer drug afatinib is likely to be approved this year as a first-line treatment, based on oncologist interviews, but experts agreed it would most likely be utilized in the second-line setting. Oncologists told this news service they will most likely use another EGFR inhibitor, Astellas/Roche’s Tarceva (erlotinib) first, as afatinib has not been proven to have a better response rate compared to Tarceva. Boehringer’s afatinib may also cause slightly higher toxicity and side-effects in patients compared to Tarceva.

In other news, Kythera’s Phase III study for ATX-101, a potential treatment for double chin fat reduction, was viewed favorably by physicians. ATX-101 is a synthetically derived formulation of deoxycholic acid, a naturally occurring molecule found in the body that aids in fat metabolism. Patients with mild-to-moderate skin laxity are likely to be the main candidates for ATX-101 if approved. Contouring agents like Allergan’s Botox (onabotulinumtoxinA) might be used to complement the drug’s effects, experts told this news service.

Physician feedback for Novartis’ multiple myeloma agent panobinostat was not so promising. Panobinostat’s preliminary safety data reported 36.2% of patients experienced thrombocytopenia, 14.5% had diarrhea, 13% had anemia and 11.4% had neutropenia. In addition, 26.2% of patients also suffered peripheral neuropathy. While Merck’s Zolinza (vorinostat) also has significant toxicity issues and has no survival benefit, it is still a better HDAC inhibitor than panobinostat, one oncologist noted.